Apparatus and method for targeting a body tissue

ABSTRACT

An apparatus for targeting a desired target site on a body tissue that separates a first body cavity from a second body cavity of a patient includes a catheter having a longitudinally extending catheter lumen and adapted to provide access to the first body cavity. A framing member has a collapsed condition in which the framing member is adapted for insertion into the first body cavity through the catheter lumen and an expanded condition in which the framing member is adapted for placement within the first body cavity. The framing member has a framing member body. At least one target point is carried by the framing member and is adapted for placement adjacent the desired target site. At least one target pathway is attached to at least one target point. At least a portion of the target pathway extends through the catheter lumen. The target pathway is substantially spaced apart from the framing member body. A method of using the apparatus is also described.

RELATED APPLICATIONS

This application is a continuation-in-part of U.S. patent applicationSer. No. 11/867,774, filed Oct. 5, 2007, which claims priority from U.S.Provisional Patent Application Ser. No. 60/850,147, filed Oct. 6, 2006,the subject matter of which is incorporated herein by reference.

TECHNICAL FIELD

The present invention relates to an apparatus and method for targeting abody tissue and, more particularly, to an apparatus and method fortargeting a desired target site on the body tissue.

BACKGROUND OF THE INVENTION

The typical human heart 100, a portion of which is shown in FIG. 1,includes a right ventricle, a right atrium 102, a left ventricle, and aleft atrium 104. The right atrium 102 is in fluid communication with thesuperior vena cava 106 and the inferior vena cava 108. A tricuspid valveseparates the right atrium 102 from the right ventricle. On theinteratrial septum 110, which is the wall separating the right atrium102 from the left atrium 104, is the fossa ovalis 112, a thin-walled,recessed area. In the heart of a fetus, the fossa ovalis 112 is open(patent foramen), permitting fetal blood to flow between the right andleft atria 102 and 104, bypassing the fetal lungs in favor of theplacental blood flow. In most individuals, this opening closes afterbirth.

A wide variety of diagnostic and therapeutic procedures have beendeveloped in which a catheter is transluminally advanced into variouschambers and across valves of the heart. The most difficult chamber ofthe heart to access with a catheter is the left atrium 104. Access tothe left atrium 104 through the pulmonary artery is not possible.Approaches from the left ventricle are difficult, may cause arrhythmias,and may present difficulty in obtaining stable catheter positioning.Accordingly, the presently preferred method of accessing the left atrium104 is through a transseptal approach, achieved by catheterization ofthe right atrium 102 with subsequent penetration of the interatrialseptum 110. The reduced wall thickness and location of the fossa ovalis112 make it a useful access point for a transseptal access puncture. Thecurrent methods of puncturing involve accessing the septum from theinferior vena cava 108. There is no device currently available thatallows safe puncture from the superior vena cave 106.

A variety of risks are attendant to transseptal catheterization, inaddition to the risks associated with normal heart catheterization. Theprimary additional risk is associated with inaccurate identification andlocalization of the interatrial septum 110 and the fossa ovalis 112 inparticular. Improper placement of the catheter tip prior to thetransseptal puncture presents the risk of puncture of tissue other thanthe interatrial septum 110, such as the aorta and/or the posterior wallof the right or left atrium 102 or 104. For this reason, catheterizationis often accompanied by fluoroscopy or other visualizing techniques toassist in properly locating the catheter tip in relation to the septum110.

The objectives of left atrial access can be either diagnostic ortherapeutic. One diagnostic use is pressure measurement in the leftatrium 104. In the setting of an obstructed mitral valve (mitralstenosis), left atrial access allows a determination of the pressuredifference between the left atrium 104 and left ventricle. Left atrialaccess also allows entry into the left ventricle through the mitralvalve. This is desirable when a mechanical aortic valve is in place. Theadvent of aortic valve replacement with mechanical artificial valves,and the increase in the aged population and growing longevity of thatpopulation subsequent to aortic valve replacement, brings a greater needto evaluate the late stage functionality of such artificial valves.

Diagnostic measurement of the left ventricular pressures is, therefore,desirable to allow evaluation of mechanical artificial aortic valvespost-replacement. Crossing these mechanical artificial valves retrogradefrom the aorta may be nonoptimal; therefore, access to the leftventricle by an antegrade route using a transseptal puncture isgenerally the preferred approach. Once a catheter has been placed in theleft atrium 104 using the transseptal approach, access to the leftventricle can be gained by advancing catheters across the mitral valve.

Many diagnostic indications exist for left atrial pressure measurementsin addition to evaluating the functionality of artificial mitral valves.Other diagnostic indications for accessing the left ventricle via theantegrade transseptal approach include aortic stenosis, when acardiologist is unable to pass a catheter retrograde into the leftventricle, and some disease states where the antegrade approach isconsidered preferable, such as subaortic obstruction.

Presently, the therapeutic objectives of left atrial access areprimarily two-fold. The first is mitral valvuloplasty which representsan alternative to surgical procedures to relieve obstruction of themitral valve. The second main therapeutic objective is forelectrophysiological intervention in the left atrium 104 via catheterablation. Catheter ablation involves the placement of energy, typicallyradio frequency (RF) from an electrode, through a catheter into variousareas of the heart 100 to eradicate inappropriate electrical pathwaysaffecting the heart function. When these locations are in the leftatrium 104, the catheter through which the RF electrode is placedtypically is itself placed into the left atrium 104 with transseptalcatheterization. More recently, therapeutic treatment of the left atrialappendage to reduce the risk of embolic stroke has also been proposed.

In addition to the above, left atrium 104 access may be desirable forpulmonary vein isolation, atrial appendage closure, patent foramenovalis closure, and aortic valve replacement or valvuloplasty. Despiteclinical acceptance of a wide variety of procedures which require accessto the left atrium 104, however, significant room for improvementremains in the actual access technique. For example, the step oflocating an appropriate site on the interatrial septum 110, such as thefossa ovalis 112, is highly technique-dependent and can be inaccurate.Such inaccuracy may increase procedure time and/or create a risk thatthe needle will pierce a heart structure in an unnecessary andpotentially undesirable location. Another problem is that the needle mayslip while advancing toward the interatrial septum 110, resulting in aninadvertent puncture into surrounding structures within/defining theright atrium 102 before the needle even reaches the interatrial septum110. This type of undesired puncture is particularly a risk when theleft atrium 104 is large and causes the interatrial septum 110 to bulgeinto the right atrium 102.

In addition to the example of accessing the left atrium 104 through theinteratrial septum 110, there are other occasions when it may bedesirable to access a body cavity from a nearby hollow structure(vascular or otherwise) which is easier to access. Broadly, “inside-out”access to a number of different body structures could be useful in manydifferent surgical situations. For example, a surgeon may wish toprovide a cannula in the heart 100, place a conduit in an artery orvein, or to connect two adjacent body cavities by puncturing from one tothe other and placing a conduit between the cavities.

Moreover, and more broadly, there are many reasons for a surgeon todesire precise location of a target site within the body, whether or notthe target site is to be punctured.

SUMMARY OF THE INVENTION

In an embodiment of the present invention, an apparatus for targeting adesired target site on a body tissue that separates a first body cavityfrom a second body cavity of a patient is described. The apparatusincludes a catheter having a longitudinally extending catheter lumen andadapted to provide access to the first body cavity. A framing member hasa collapsed condition in which the framing member is adapted forinsertion into the first body cavity through the catheter lumen and anexpanded condition in which the framing member is adapted for placementwithin the first body cavity. The framing member has a framing memberbody. At least one target point is carried by the framing member and isadapted for placement adjacent the desired target site. At least onetarget pathway is attached to at least one target point. At least aportion of the target pathway extends through the catheter lumen. Thetarget pathway is substantially spaced apart from the framing memberbody. In an embodiment of the present invention, a method for puncturinga body tissue of a patient at a desired target site is described. Acatheter having a longitudinally extending catheter lumen is insertedinto the patient. The catheter is advanced into a first body cavity ofthe patient. A framing member having a framing member body and carryingat least one target point is provided. The target point is adapted forplacement adjacent the body tissue to indicate the desired target site.At least one target pathway attached to at least one target point isprovided. At least a portion of the target pathway extends through thecatheter lumen, and the target pathway is substantially spaced apartfrom the framing member body. The framing member is inserted in acollapsed condition into the first body cavity through the catheterlumen. The framing member is expanded into an expanded condition withinthe first body cavity. The target point is positioned adjacent thedesired target site. A puncture needle is inserted into the first bodycavity through the catheter lumen. The puncture needle is connected tothe target pathway. The puncture needle is guided to the target pointwith the target pathway. The body tissue is punctured with the punctureneedle at the desired target site.

BRIEF DESCRIPTION OF THE DRAWINGS

For a better understanding of the invention, reference may be made tothe accompanying drawings, in which:

FIG. 1 is a schematic cross-sectional view of a heart, showing a firstexample use environment;

FIG. 2 is a side view of a first embodiment of the present invention ina first condition;

FIG. 3 is a side view of the embodiment of FIG. 2 in a second conditionwithin a heart;

FIG. 4 is a side view of the embodiment of FIG. 2 in a third conditionwithin a heart;

FIG. 5 is a side view of the embodiment of FIG. 2 in the third conditionwithin a heart;

FIG. 6 is a partial side view of a second embodiment of the presentinvention;

FIG. 7 is a side view of the second embodiment of FIG. 6 in a firstcondition;

FIG. 8 is a side view of the second embodiment of FIG. 6 in a secondcondition;

FIG. 9 is a side view of the second embodiment of FIG. 6 in a thirdcondition;

FIG. 10 is a side view of a third embodiment of the present invention ina first condition;

FIG. 11 is a side view of the third embodiment of FIG. 10 in the firstcondition within a heart;

FIG. 12 is a side view of the third embodiment of FIG. 10 in a secondcondition within a heart;

FIG. 13 is a side view of the third embodiment of FIG. 10 in a thirdcondition within a heart;

FIG. 14 is a side view of an alternate configuration of the thirdembodiment of the present invention in a first condition;

FIG. 15 is a partial side view of a fourth embodiment of the presentinvention;

FIG. 16 is a side view of a fifth embodiment of the present invention ina first condition;

FIG. 17 is a side view of the fifth embodiment of FIG. 16 in a secondcondition;

FIG. 18 is a side view of the fifth embodiment of FIG. 16 in a thirdcondition;

FIG. 19 is a schematic view of a second example use environment of anyembodiment of the present invention;

FIG. 20 is a schematic view of a third example use environment of anyembodiment of the present invention;

FIG. 21 is a schematic view of a fourth example use environment of anyembodiment of the present invention;

FIG. 22 is a schematic view of a fifth example use environment of anyembodiment of the present invention;

FIG. 23 is a schematic view of a sixth example use environment of anyembodiment of the present invention;

FIG. 26 is a partial side view of an eighth embodiment of the presentinvention; and

FIG. 27 is a side view of the eighth embodiment of FIG. 26 in a secondcondition within a heart.

DESCRIPTION OF EMBODIMENTS

In accordance with the present invention, FIG. 2 depicts a firstembodiment of an apparatus 214 for targeting a desired target site on abody tissue. Throughout this description, the desired target site ispresumed to be an interatrial septum 110 that separates a right atrium102 from a left atrium 104 of a heart 100, but (as discussed below) maybe any body tissue of a patient. Moreover, this description presumesthat the desired target site is being targeted for puncture. However,the apparatus 214 could be useful in precisely locating a desired targetsite which is being targeted for any reason, without limitation. Forexample, it may be useful to target a desired target site withoutnecessarily puncturing or otherwise altering the target site whenrepairing an atrial septum defect (such as a patent foramen ovalis), fordissection/location/alignment of any body structure, when repairing aperivalvular leak, for pinpointing a small branch from a blood vessel(i.e., targeting a void in a body tissue rather than a point on the bodytissue), or the like. One of ordinary skill in the art could readily usethe apparatus 214 for any application in which a target site is locatedfor any reason or as a part of any procedure. For example, a target sitecould be helpful in a gastrointestinal or genitourinary tract accessprocedure, to put in a shunt (e.g., for a neurological procedure), orfor any other desirable procedure. However, for clarity, the belowdescription presumes that the targeting is being accomplishedpreparatory to a puncture procedure.

The apparatus 214 includes a catheter 216 (shown in dashed line in FIG.2) having a longitudinally extending catheter lumen 218 and adapted toprovide access to the right atrium 102 through a blood vessel, such asthe superior or inferior vena cava 106 or 108. For ease of description,the desired target site will be presumed to be the fossa ovalis 112 whenthe desired target site is located on an interatrial septum 110. Anydesired target site, however, may be targeted by the apparatus 214.

A framing member 220 has a collapsed condition (shown as the firstcondition of FIG. 2) in which the framing member is adapted forinsertion into the blood vessel through the catheter lumen 218. Theframing member 220 shown in FIG. 2 is a loop of thin, flexible wirehaving a framing member body 226 and may be made of any suitablematerial such as, for example, a woven, drawn, or otherwise formedstrand of Nitinol, stainless steel, nylon, plastic, or any othermaterial as desired. The framing member 220 may be radiopaque, in wholeor part, to facilitate positioning within the right atrium 102 asdesired. The framing member 220 also has an expanded condition (shown asthe second and third conditions in FIGS. 3 and 4) in which the framingmember is adapted for placement within the right atrium 102. In thefirst embodiment, the framing member 220 is self-expanding and should bedesigned to have a resting configuration compatible with the rightatrium 102. The framing member 220 may include a shaped feature, such asthe protrusion 224, which is adapted to enter the superior vena cava 106or another structure and facilitate rotational positioning of theframing member 220 within the right atrium 102. For example, the framingmember 220 could be made from a memory alloy having the restingconfiguration shown in FIG. 4 but selectively compressible into thecatheter 216 for delivery to the right atrium 102.

The framing member 220 carries at least one target point 228 (one shownin FIGS. 2-5). The target point 228 is adapted for placement adjacentthe interatrial septum 110 to indicate the desired target site. Thetarget point 228 may have an associated radiopaque marker (not shown) orotherwise be visible to an external imaging system or other remotedetection system (not shown) when located within the patient's heart100. The target point 228 may be affixed, as shown in FIG. 2, to theframing member body 226. It is contemplated that the target point 228may be affixed in either a movable or nonmovable manner with respect tothe framing member 220.

Each target point 228 may be attached to a target pathway, such as, inthe embodiments of FIGS. 2-23, a target wire 230 (shown in dash-dot linein the Figures). As shown in the Figures, the target pathway includesone end (here, the end attached to the target point 228) which istouching or directly adjacent to the framing member 220. The remainderof the target pathway is substantially spaced apart from the framingmember body 226. In other words, the target pathway and the framingmember body 226 are substantially separate structures, in the exampleembodiments depicted in the Figures, which “meet” at the target point(s)228. While it would be possible for the target pathway to be coaxialwith, and/or coextend with, at least a portion of the framing member220, this situation is not shown in the Figures and will not bedescribed further herein. (The relatively small portion of the targetpathway which is attached to the target point 228 may be locatedadjacent or even in contact with the framing member body 226 withoutdestroying this “substantial spacing apart”, however). Optionally, atleast a portion of the target pathway may extend through the catheterlumen 218.

The target wire 230 extends through the catheter lumen 218 between anexternal power source (not shown) and the target point 228. The targetwire 230 may selectively provide at least one of an electrical and amechanical signal to the target point 228 to indicate a position of thetarget point within the heart 100. Such indication may be made in avisual manner, and/or may be made in cooperation with an externalimaging or other remote detection system.

For example, the target wire 230 could transmit a mechanical vibrationto the target point 228 to cause the target point to move slightly. Theexternal imaging system would detect such a motion and responsivelyindicate the location of the target point in relation to the target siteon the interatrial septum 110 or another heart 100 structure. Similarly,the target wire 230 could carry an electrical current and cause thetarget point 228 to emit an electromagnetic signal having certainpredetermined signal characteristics. The external imaging system thenwould detect the emitted signal and responsively indicate the locationof the target point 228 within the heart 100.

A puncture needle 232 is provided. The puncture needle 232 is adaptedfor insertion through the catheter lumen 218 and into the right atrium102. Optionally, and as shown in the drawings, the puncture needle 232may be contained within a needle catheter 233. The puncture needle 232has longitudinally spaced first and second needle ends 234 and 236,respectively, with the first needle end 234 being operative to puncturethe interatrial septum 110 at the desired target site, which isoptionally the fossa ovalis 112, as discussed herein. The second needleend 236 may be attached to a needle wire 238, which allows the user toremotely control the motion of the puncture needle 232 inside the needlecatheter 233. The puncture needle 232 could have a hollow bore (notshown), through which a guidewire could be extended, as discussed below.

Optionally, the needle catheter 233 may be connected to the target wire230 in a “monorail”-like manner, using a needle coupler 240. Thisconnection allows the target wire 230 to guide the puncture needle 232to the desired target site quickly and efficiently.

When a needle coupler 240 or other system/structure is used to guide thepuncture needle 232, the target point 228 may need to be calibrated orotherwise adjusted with respect to the desired target site. One ofordinary skill in the art can readily compensate for any offset distancebetween the target point 228 and the actual position of the first needleend 234 which may be caused by the needle coupler 240, needle catheter233, or other guidance structure. While often the target point 228 maybe superimposed—from the viewpoint of the target pathway—upon thedesired target site, it is also contemplated that the target point 228may have a desired offset distance and/or direction from the desiredtarget site to allow for desired precision in guiding the punctureneedle 232 to the desired target site. In the former arrangement, thetarget point 228 may block access to the desired target site in a waythat could be alleviated via the latter arrangement for particularapplications of the present invention.

In most embodiments of the present invention, it is contemplated thatthe target point 228 will be located adjacent to, or directly upon, thedesired target site. It is also contemplated, though, that the targetpoint 228 may be located upon the framing member 220 at a locationsubstantially spaced from the desired target point (e.g., a locationopposite the desired target point such as on a diametrically opposedportion of a body lumen therefrom). One of ordinary skill in the artwill realize that such remote location may inherently reduce theprecision of indication of the desired target site, however, in certainapplications of the present invention.

The operation of the first embodiment of the present invention isdepicted in the sequence of FIGS. 2-5. As discussed above, the targetwire 230 and needle coupler 240 are optional, but are shown in FIGS. 2-5for clarity of description of the first embodiment of the presentinvention.

First, the catheter 216 is inserted into the patient's vascular systemand guided through the vascular system into or near the right atrium 102of the heart 100, with the catheter 216 shown in FIG. 3 as entering theright atrium 102 through the inferior vena cava 108. However, thecatheter 216 could instead enter the right atrium 102 through thesuperior vena cava 106 or in another manner. Regardless of the mannerand location in which the catheter 216 is guided into position withinthe right atrium 102, the framing member 220 may be inserted, in thefirst (collapsed) condition, into the right atrium through the catheterlumen 218. The framing member 220, in the collapsed condition, need notprotrude from the catheter lumen 218 within the right atrium 102, butmay do so if desired.

Optionally, the catheter 216 may be inserted a relatively deep distanceinto the right atrium 102 or through the right atrium and into thesuperior vena cava 106, and the framing member 220 may be maintained atthat insertion depth within the right atrium or superior vena cava. Thecatheter 216 may then be at least partially retracted from the rightatrium 102, thus moving relative to the framing member 220 andunsheathing the framing member. This technique may be useful when aprotrusion 224 or other nonuniformity of the framing member 220 isprovided to mate with the superior vena cava 106. Otherwise, thecatheter 216 may be maintained at a relatively shallow insertiondistance into the right atrium 102, as shown in FIGS. 3-5, and theframing member 220 may then be moved into the right atrium, in anadvancement direction 346, to emerge from the catheter.

The framing member 220 is then expanded into the second (expanded)condition within the right atrium 102, as shown in the sequence of FIGS.3-4. This expansion may be done in whole or in part, and as quickly asdesired, depending upon the particular application of the apparatus 214.As mentioned above, the framing member 220 of the first embodiment isself-expanding into the expanded condition and may include a protrusion233 for locating the framing member within the right atrium 102.

As the framing member body 226 is brought into position within the rightatrium 102 as desired, the framing member 220 may be manipulated toposition the target point 228 adjacent the interatrial septum 110.Optionally, the target point 228 may contact the interatrial septum 110.The location of the target point 228 on the framing member 220 should bepredetermined to facilitate positioning adjacent the interatrial septum110 as desired.

Optionally, the target point 228 may be slidably fastened to, orotherwise movable with respect to, the framing member 220. In such case,the target wire 230, when present, may assist in moving the target point228 along the framing member 220 and into the desired position adjacentthe interatrial septum 110.

When the framing member 220 has been expanded into the right atrium 102and arranged as desired to bring the target point 228 into the desiredposition adjacent the interatrial septum 110, at least a portion of theframing member body 226 may lie in contact with the interatrial septum.That is, the framing member 220 may contact one or more locations on, orareas of, the interatrial septum 110.

The right atrium 102 includes an internal right atrium surface 348, ofwhich the interatrial septum 110 forms a portion. The framing member 220may exert a positive pressure on any areas of the internal right atriumsurface 348 when in the expanded condition. The framing member 220 isoptionally designed to brace against areas of the internal right atriumsurface 348 remote from the interatrial septum 110 in order to maintaincontact between the target point 228 and the interatrial septum. Forinstance, the framing member 220 may be designed to be slightly largerthan the internal right atrium surface 348 in one or more dimensionswhen in the expanded condition, in order to exert a positive pressureneeded to maintain the target point 228 in a desired position.

In order to confirm that the target point 228 is located adjacent theinteratrial septum 110 as desired before the surgery proceeds, theposition of the target point 228 may be viewed within the right atrium102 using an external imaging system (not shown). The position may beestablished and viewed passively when the target point 228 includes aradiopaque or other marker.

Alternately, an active determination of the position of the target point228 may be made, such as by selectively providing at least one of anelectrical and a mechanical signal through the target wire 230 to thetarget point 228. An external imaging or other remote detection systemmay be used to sense a position-indication motion or signal produced bythe target point 228 responsive to the electrical and/or mechanicalsignal. The user can then review the output of the remote detectionsystem to determine the location of the target point 228 within theright atrium 102. This position-checking process may be repeated asneeded at any suitable time throughout the targeting procedure.

A puncture needle 232 may be inserted into the catheter 216, through useof a needle catheter 233, at any suitable time before or during theseptal puncture procedure. The needle catheter 233 may be coupled to thetarget wire 230, when present, or may be guided independently, aspreviously discussed. For ease of description below, it is presumed thata needle coupler 240, which may be a loop of suture thread, a monorailcatheter coupler, or have any other suitable structure, attaches theneedle catheter 233 to the target wire 230.

The needle catheter 233 is passed through the catheter lumen 218 intothe right atrium 102 and is guided to the target point 228, advancing inthe advancement direction 346. As shown in FIGS. 4 and 5, this guidancemay occur along the target wire 230. When the needle catheter 233reaches the interatrial septum 110 at or adjacent the desired targetsite, the puncture needle 232 is moved in the advancement direction 346relative to the needle catheter 233. This motion should be sufficientfor the puncture needle 232 to puncture the interatrial septum at thedesired target site and allow the first needle end to enter the leftatrium 104.

Once the puncture needle 232 has passed at least partially through theinteratrial septum 110, the left atrium 104 may be accessed through thepuncture at the target site in any suitable manner. For example, aguidewire 550 could be advanced through the needle catheter 233,optionally following the needle wire 238, and into the left atrium 104.As shown in FIG. 5, the guidewire 550, when present, may be insertedthrough a hollow bore (not shown) of the puncture needle 232 and intothe left atrium 104. Once the guidewire 550 is in place, the punctureneedle 232 and needle wire 238, and optionally the needle catheter 233,can be removed from the catheter 216. With the guidewire 550 in place,the left atrium 104 can be accessed as desired in a known manner as thesurgical procedure progresses.

The apparatus 214, or portions thereof, may be removed from the rightatrium 102 if desired, by reversing all or part of the above process.The guidewire 550, particularly, may be left in place after removal ofother portions of the apparatus 214 to facilitate access to the leftatrium 104. Optionally, the catheter 216 may remain in position afterthe puncture is made to continue right and left atrium 102 and 104access as the surgery progresses, with the framing member(s) 220, targetwire(s) 230, and/or puncture needle 232 being retracted through thecatheter 216 and removed from the patient. The catheter 216, guidewire550, and any other portions of the apparatus 214 which were left inplace within the patient may be removed as the surgery concludes.

FIGS. 6-9 illustrate a second embodiment of an apparatus 214 b. Theapparatus 214 b of FIGS. 6-9 is similar to the apparatus of FIGS. 2-5and therefore, structures of FIGS. 6-9 that are the same as or similarto those described with reference to FIGS. 2-5 have the same referencenumbers with the addition of the suffix “b”. Description of commonelements and operation similar to those in the previously describedfirst embodiment will not be repeated with respect to the secondembodiment.

The framing member 220 b of the second embodiment is made up of aplurality of framing strands 652, with each framing strand 652 beingsimilar to the framing member 220 of the first embodiment. The framingstrands 652 are optionally attached together with framing cross members654, shown in dashed line in FIG. 6. Whether or not framing crossmembers 654 are provided, the framing member 220 b carries a pluralityof target points 229 forming a target grid 650. The target grid 650 isshown in the Figures as being rectilinear. However, the target grid,like all structures described herein, could have any suitable two- orthree-dimensional shape, profile, or configuration. Each target point229 may have a corresponding target wire 230 b, most of which areomitted throughout the Figures in all embodiments for clarity. Thosetarget wires 230 b shown in the Figures as examples have no particularsignificance distinguishing them from the omitted target wires 230 b.

The framing member 220 b of the second embodiment is expanded into theexpanded condition much like the framing member 220 of the firstembodiment, as shown in the sequence of FIGS. 7-9. The catheter 216 band framing member 220 b are moved relatively, such as by movement ofthe framing member in the advancement direction 346 b. The framingmember 220 b of the second embodiment is self-expanding, as shown in thesequence of FIGS. 7-9, and is designed to occupy at least a portion ofthe right atrium 102, as with the framing member 220 of the firstembodiment.

The framing member 220 b is used to help position at least a portion ofthe target grid 650 adjacent the interatrial septum 110 b. The positionof the target grid 650 within the right atrium 102 b is then determined.Optionally, this is done by viewing the target grid 650 using anexternal imaging or other remote detection system (not shown).

For example, a target wire 230 b corresponding to a test target point229, for example, the top right target point 229 (as viewed in FIG. 7),may be used to selectively provide at least one of a mechanical and anelectrical signal to that test target point 229. The resultant signalproduced by the test target point 229 may then be viewed with theexternal imaging or other remote detection system to determine theposition of that test target point 229 within the right atrium 102 b.This process can be repeated as needed until the position of each targetpoint 229 is known, either directly or through extrapolation from other,directly detected, target points 229.

Once the position of the target grid 650 is known, a closest targetpoint 229 to a desired target site, or another target point 229 having adesired relationship with the desired target site, may be chosen. For apuncture procedure in which a target wire 230 b is used to guide theneedle catheter 233 b, the needle coupler 240 b is attached to thetarget wire 230 b corresponding to that selected target point 229.Whether or not the needle catheter 233 b is guided by the target wire230 b, the puncture needle 232 b can be guided to the selected targetpoint 229 and puncture the interatrial septum 110 b at the desiredtarget site in much the same manner as described above.

FIGS. 10-13 illustrate a third embodiment of an apparatus 214 c. Theapparatus 214 c of FIGS. 10-13 is similar to the apparatus of FIGS. 2-5and therefore, structures of FIGS. 10-13 that are the same as or similarto those described with reference to FIGS. 2-5 have the same referencenumbers with the addition of the suffix “c”. Description of commonelements and operation similar to those in the previously describedembodiments will not be repeated with respect to the third embodiment.

In the third embodiment of FIG. 10, the framing member 220 c may be anelongated framing member having longitudinally spaced first and secondframing member ends 1058 and 1060, respectively, separated by anintermediate framing member body 226 c. The catheter 216 c has acatheter outlet end 1062 in fluid communication with the right atrium102 c. The framing member 220 c depicted in FIGS. 10-13 is a fairlystiff but elastically deformable wire, with the first framing member end1058 anchored to the catheter 216 d at an anchor point 1064 adjacent thecatheter outlet end 1062. The framing member 220 c does not need to beself-expanding in the third embodiment of the present invention becausethe expansion may be effected by outside forces acting on the framingmember 220 c.

The anchoring attachment may be static, such as a weld, or dynamic, suchas a pivoting joint. The anchor point 1064 may be at any location on theinside or outside of the catheter 216 c and may be readily chosen for aparticular application of the apparatus 214 c by one of ordinary skillin the art. The anchor point and/or type may be chosen to steer theframing member body 226 c to expand asymmetrically, as shown in FIGS.12-13.

Deployment of the apparatus 214 c is shown in the sequence of FIGS.11-13. To expand the framing member 220 c into the second, expandedcondition within the right atrium 102 c, the second framing member end1060 is advanced toward the right atrium, as indicated by theadvancement direction arrow 346 c. Since the first framing member end1058 is affixed to the catheter 216 c at the anchor point 1064,advancement of the second framing member end 1060 will cause at least aportion of the framing member body 226 c to bow out into the rightatrium 102 c, as shown in FIGS. 12 and 13.

Once the framing member 220 c has reached the expanded condition (shownas the second condition in FIG. 12), the position of the target point228 c can be checked and adjusted as needed, optionally with theassistance of a radiopaque marker or of a target wire 230 c and remotedetection system, as described above. The needle catheter 233 c, whenused in a puncture procedure, may be guided to the desired target sitein any suitable manner, such as along the target wire 230 c using aneedle coupler 240 c, as depicted in FIGS. 12 and 13. The interatrialseptum 110 c may then be punctured, a guidewire 550 c optionally placedinto the left atrium 104, and the apparatus 214 c withdrawn from theheart 100 c, as with the first and second embodiments described above.

FIG. 14 depicts an alternate configuration of the third embodiment. Thealternate configuration bears similarities to the second embodiment, inthat a plurality of framing strands 652 c make up the framing member 220c, and a plurality of target points 228 c are arranged in a target grid656. However, the multi-strand alternate configuration of FIG. 14 isdeployed similarly to the single-strand framing member 220 c previouslydescribed as the third embodiment. The framing strands 652 c may beconnected by framing cross members (not shown), or the apparatus 214 cof the alternate configuration depicted in FIG. 14 may otherwiseincorporate any suitable features from either the second or thirdembodiment of the present invention.

FIG. 15 illustrates a fourth embodiment of an apparatus 214 d. Theapparatus 214 d of FIG. 15 is similar to the apparatus of FIGS. 2-5 andtherefore, structures of FIG. 15 that are the same as or similar tothose described with reference to FIGS. 2-5 have the same referencenumbers with the addition of the suffix “d”. Description of commonelements and operation similar to those in the previously describedembodiments will not be repeated with respect to the fourth embodiment.

The framing member 220 d of the fourth embodiment has a flat, elongatedribbon-like structure, at least for the planar framing member body 226 dportion thereof. The framing member 220 d may be self-expanding, but isnot necessarily so. The first and second framing member ends (not shown)may be of any suitable configuration. A plurality of target points 228 dare arranged in a target grid 656 d on a planar surface of the framingmember body 226 d. Target wires 230 d may connect one or more targetpoints 228 d with one or more external power sources, for ease oflocation of the respective target points 228 d within the right atrium.

The framing member 220 d may be at least partially perforated or formedfrom mesh, an example portion of which is shown in dotted line in FIG.15, to allow for the puncture needle or other structures to easilyextend and/or pass through the thickness of the framing member 220 d.

The framing member 220 d of the fourth embodiment may be deployedsimilarly to the framing members 220 b or 220 c of the previouslydescribed second or third embodiments of the present invention. That is,the planar framing member body 226 d and the target grid 656 d may bepart of either a closed-loop framing member 220 b as in the secondembodiment, or an anchored framing member 220 c as in the alternateconfiguration of the third embodiment. In either case, the framingmember body 226 d is positioned in the right atrium with at least aportion of the target grid 656 d adjacent the interatrial septum. Thetarget point 228 d location procedure may then be carried out asdescribed above, with the interatrial septum being punctured (ifdesired) and the apparatus 214 d removed from the right atrium as withthe other embodiments of the present invention.

FIGS. 16-18 illustrate a fifth embodiment of an apparatus 214 e. Theapparatus 214 e of FIGS. 16-18 is similar to the apparatus of FIGS. 2-5and therefore, structures of FIGS. 16-18 that are the same as or similarto those described with reference to FIGS. 2-5 have the same referencenumbers with the addition of the suffix “e”. Description of commonelements and operation similar to those in the previously describedembodiments will not be repeated with respect to the fifth embodiment.

The apparatus 214 e of the fifth embodiment includes a framing member220 e having a plurality of framing strands 652 e connected by flexibleframing cross members 654 e. The framing strands 652 e areself-expanding and are arranged to draw the framing cross members 654 etaut in the second, expanded condition. The framing member 220 e is heldin a compressed configuration to fit within the catheter 216 e in thefirst, collapsed condition.

The framing member 220 e supports a plurality of target points 228 e ina target grid 656 e. Any number of target points 228 e may have anassociated target wire 230 e. Unlike the previously describedembodiments, the target grid 656 e is located at or near the firstframing member end 1058 e of the framing member 220 e in the fifthembodiment.

To deploy the framing member 220 e of the fifth embodiment, the framingmember and catheter 216 e are relatively moved, such as by extending theframing member in the advancement direction 346 e. As depicted in thesequence of FIGS. 17-18, the framing strands 652 e begin to self-expandand separate from each other as they are released from the catheteroutlet end 1062 e. The framing cross members 654 e restrain the framingstrands 652 e and thereby retain the target points 228 e in the targetgrid 656 e configuration.

In FIG. 18, the framing member 220 e has reached the second, expandedcondition, with the target grid 656 e held apart from the catheter 216 ein a cantilevered manner. The framing member 220 e may then bemanipulated to bring the target grid 656 e adjacent the interatrialseptum. The framing member 220 e may be bent or curved in apredetermined manner to facilitate placement of the target grid 656 e asdesired with respect to the interatrial septum. Optionally, the framingstrands 652 e are of a sufficiently stiff material to allow for positivepressure to be applied against the interatrial septum by the target grid656 e.

Once the target grid 656 e is in the desired position within the rightatrium 102, the target point 228 e location procedure may be carried outas described above, with the interatrial septum 110 being punctured andthe apparatus 214 e removed from the right atrium as with the otherembodiments of the present invention.

As alluded to previously, any of the first through fifth embodiments ofthe present invention could be used to target a desired target site onany body tissue. Additionally, the target site could be chosen for anyreason or because of any characteristic; as discussed previously,locating a puncture site is only one of many possible uses for thepresent invention. The body tissue could separate first and second bodycavities of any portion of the patient's anatomy. As used herein, “bodycavity” simply means an area of the patient's body from which or towhich access is desired, such access to be provided by puncturing thebody tissue. The first and second body cavities in the previouslydescribed use environment are the right and left atria 102 and 104,respectively. A “body cavity” need not be a tightly enclosed or definedopen volume within the body, but could be any lumen within, or spacebetween, any body structures, no matter how minimal. For ease ofdescription, access to or from a “body cavity” will be considered hereinto also encompass access between an internal body location and the spaceexternal to the patient's body (for example, puncturing through theabdominal skin inward to or outward from the peritoneal cavity fordirect access thereto through the patient's abdomen).

FIGS. 19-23 schematically depict various example use environments of anyembodiment of the present invention, in addition to the first exampleuse environment previously depicted and described with respect to thefirst through fifth embodiments. However, the apparatus 214 of the firstembodiment will be shown in schematic form in these Figures, forsimplicity. Additionally, operation of several embodiments of theapparatus 214 has been previously described and will not be repeatedbelow.

FIG. 19 is a partial cross-sectional view of a heart 100 having rightand left atria 102 and 104. In the second example use environmentdepicted, the catheter 216 has traveled through the inferior vena cava108 to the right atrium 102. The apparatus 214 has already been usedonce to puncture through the interatrial septum 110, with the catheter216 following the framing member 220 through the interatrial septum.However, the catheter 216 could instead be held within the right atrium102, with only the framing member extending through the interatrialseptum 110, as desired.

In the second example use environment of FIG. 19, the apparatus 214 isin a desired position on the body tissue forming a left atrial appendage1966 of the heart 100. Arrow A depicts a possible path for a needle (notshown) to exit the left atrial appendage 1966 by a puncture at or nearthe target point 228, when such egress is desired. Such precise targetsite location within the left atrial appendage 1966 could be useful inmany different surgical procedures. It is well-known that blood oftenclots within the left atrial appendage 1966, causing a risk of stroke,so it may be desirable, for example, to locate and/or prepare a targetsite for anchoring a blocking device within the left atrial appendage.

Since the left atrial appendage 1966 is not a “working tissue” of theheart 100, a puncture therethrough (and the resultant scar tissue) willnot hinder ongoing operation of the heart. Accordingly, access into orout of the heart 100 may be desirably provided through the left atrialappendage 1966 wall, to avoid damaging otherwise intact structures andtissues of the heart during access. For example, the catheter 216 may beinserted into the body endovascularly, as shown in FIG. 19, and the leftatrial appendage 1966 punctured (with targeting assistance from theapparatus 214). The catheter 216 could then be advanced through the leftatrial appendage 1966 and through the chest cavity structures in anoutward direction. The apparatus 214 could then be used to preciselytarget an emergence location for the catheter 216 to pass through thepatient's chest wall and provide direct percutaneous access to the heart100 without necessitating a potentially damaging and imprecise cut-downprocedure from the patient's chest wall toward the heart. Thus, thepatient's chest structure could be more readily navigated, and possiblypreserved, during percutaneous procedures (for example, aortic or mitralvalve replacements) using the apparatus 214 and the described“inside-out” technique than if the heart 100 were to be blindly accessedfrom the outside in, as is traditionally done. Further, chest incisionsand/or exposure of the heart 100 to the ambient atmosphere, forstabilizing the cardiac structures, are avoided through use of thisinside-out access.

FIG. 20 is a schematic external view of the heart 100, depicting a thirdexample use environment of any embodiment of the present invention. Thethird example use environment is similar to the second example useenvironment, except that instead of the left atrial appendage 1966, theapparatus 214 is being used to locate a target site within a rightatrial appendage 2068. The catheter 216 has previously been insertedinto the right atrium 102 in any suitable manner, and the framing member220 is depicted in FIG. 20 as being located adjacent the body tissuemaking up the right atrial appendage 2068 wall. The target point 228 inFIG. 20 is located adjacent an inner surface of the right atrialappendage 2068 wall, ready to guide a needle (not shown), if desired, topuncture from that location within the right atrial appendage 2068outward from the heart 100, possibly in the direction of Arrow A.Inside-out access through the right atrial appendage 2068 in this mannermay be useful, for example, in conducting surgical procedures on one ormore of the tricuspid valve, pulmonary valve, or interatrial septum.

In either of the second or third example use environments, or any otheruse environment, the apparatus 214 can be used in the reverseorientations from those depicted. That is, the apparatus 214 can enterthe patient's body from outside the heart 100 in any desired manner, andthe target point 228 can be used to accurately identify a desired targetsite on either the left or right atrial appendage 1966 or 2068 oranother portion of the heart 100, through which the interior of theheart can be accessed. Though the left and right atrial appendages 1966and 2068 are used as examples herein, the apparatus 214 could be used atany location on the heart 100, internally or externally, to assist inproviding either inward or outward access through a heart wall.

A fourth example use environment of any embodiment of the presentinvention is depicted in FIG. 21. As previously mentioned, blood canstagnate within the left atrial appendage 1966 in an undesirable mannerwhich results in hazardous clotting therein. Blood normally flows to theleft atrium 104 through the left pulmonary vein 2170, and if a portionof the inflowing blood could be diverted from the left pulmonary veinthrough the left atrial appendage 1966, the resultant “flushing” actioncould keep the blood within the left atrial appendage from stagnatingand clotting. Therefore, a flushing conduit 2172 may be used to connectthe left pulmonary vein 2170 directly to the left atrial appendage 1966to facilitate such an alternate flow path.

As shown in FIG. 21, the apparatus 214 has already been used to puncturethe walls of the left pulmonary vein 2170 and the left atrial appendage1966, and the flushing conduit 2172 is depicted as extendingtherebetween. One of ordinary skill in the art can readily determine theinsertion points, direction/order of puncture of the left pulmonary vein2170 and the left atrial appendage 1966 walls, and method of placing theflushing conduit 2172 for a particular patient. The apparatus 214 may beespecially useful in this fourth example use environment because of theneed for extremely precise positioning of the ends of the flushingconduit 2172 to fully flush the left atrial appendage 1966 andsubstantially eliminate stagnation of blood therein.

FIG. 22 depicts a fifth example use environment, including a portion ofthe abdominal aorta 2274 and the associated common iliac artery 2276,through which the framing member 220 is depicted as extending. Thecatheter 216 has been inserted in a brachial insertion direction 2278,routed through the abdominal aorta 2274, and the apparatus is now readyto guide a needle (not shown) to puncture the common iliac artery 2276outward, in a direction such as that indicated by Arrow A (possiblytoward the abdominal wall), in the depicted configuration. In thismanner, the common iliac artery 2276 can be punctured precisely at adesired target site, avoiding surrounding vascular, neurological, orother structure, and the apparatus 214 can then be used to extendthrough the abdominal wall and outside the patient's body. Alternately,the target site could be marked or otherwise used to advantage withoutbeing punctured or altered. Once the apparatus 214 has exited the body,in a puncture procedure, a sheath or conduit can be extended through theexit point and back to the target site on the common iliac artery 2276.Because of this inside-out access procedure, the user may enter thecommon iliac artery 2276 at a specific location without fear of piercingall the way through opposing wall of the common iliac artery and“missing” the lumen thereof while damaging the opposing wall. Access inthis manner may be desirable, for example, in conducting a percutaneousaortic valve replacement procedure, or any other procedure in whichdirect access between the common iliac artery 2276 and the outside ofthe patient's body is desired.

Though not all are depicted in FIG. 22, the framing member 220 couldreach the target site shown along any of several paths. For example, theapparatus 214 could be inserted from a corresponding femoral artery (notshown) and advanced toward the depicted target site in a femoralinsertion direction 2280. Similarly, and as another example, theapparatus 214 could be inserted from a contralateral femoral artery (notshown) and advanced toward the depicted target site in a contralateralfemoral insertion direction 2282. More generally, the fifth example useenvironment depicted in FIG. 22 is merely one of a multitude oflocations within a patient's body where a blood vessel, or other firstbody cavity or lumen, can be placed into communication with the outsideof the patient's body or with at least one other body cavity, whether ornot the first body cavity is adjacent the second or more body cavities.For example, the fifth example use environment could be related to aninside-out or outside-in procedure using a carotid or subclavianstructure. Indeed, even if no puncture is carried out, the apparatus 214could be useful in locating a target site in any portion of a patient'svasculature. For example, the target site could be a void, such as ajunction point with a side branch or anastomosis location, in a wall ofa blood vessel.

In FIG. 23, a sixth example use environment of the present invention isdepicted. A blood vessel 2384 is substantially blocked by an obstruction2386, which may be a blood clot, plaque, or any other obstructivematerial. The blood vessel 2384 could be any suitable blood vessel 2384such as, but not limited to, the superficial femoral artery. In order tobypass or remove the obstruction 2386, it may be desirable to route acatheter 216 through the subintimal space 2388 defined within the vesselwall 2390 adjacent the obstruction. As shown in FIG. 23, the catheter216 has already been guided from the blood vessel lumen 2392 into thesubintimal space 2388, optionally through use of the framing member 220and associated target point 228. The apparatus 214, or portions thereof,are shown as being routed through the subintimal space 2388 in a bypassdirection 2394, traveling in parallel with the blood vessel lumen 2392while avoiding the obstruction 2386. Once the apparatus 214 has passedbeyond the obstruction 2386, the framing member 220 and target point 228can be used to help re-introduce the apparatus to the blood vessel lumen2392, possibly in the direction of Arrow A. This will establish analternate or bypass route, through the subintimal space 2388 of theblood vessel 2384, which avoids the obstruction 2386. Since thesubintimal space 2388 is very small, an apparatus 214 according to thepresent invention may be useful in ensuring that the vessel wall 2390 ispunctured precisely at the desired location and that the puncture needle(not shown) does not penetrate entirely through the subintimal space andbeyond the vessel wall 2390. As with any of the embodiments and exampleuse environments of the present invention, the apparatus 214 can assistwith precisely locating the desired target site and, as appropriate,stabilizing the puncture needle to facilitate providing access through abody tissue in a desired manner.

FIGS. 24-25 illustrate a seventh embodiment of an apparatus 214′. Theapparatus 214′ of FIGS. 24-25 is similar to the apparatus of FIGS. 2-5and therefore, structures of FIGS. 24-25 that are the same as or similarto those described with reference to FIGS. 2-5 have the same referencenumbers with the addition of a “prime” mark. Description of commonelements and operation similar to those in the previously describedembodiments will not be repeated with respect to the seventh embodiment.

As shown in FIG. 24, the target pathway in the seventh embodimentincludes a target lumen 2466, which is shown as a flexible tubularstructure which is attached to or near the target point 228′ and extendsat least a portion of the distance through the catheter lumen 218′. Forexample, the target lumen 2466 may place the target point 228′ in fluidcommunication with a location outside the patient's body. Through use ofthe target lumen 2466, a user may pass a puncture needle (omitted fromFIG. 24) through the catheter lumen 218′ and to the desired target sitewithout the use of the aforementioned needle coupler 240′ or similarguiding devices. In other words, the target lumen 2466 itself can act asa guiding device for access to the desired target site.

The target lumen 2466 may also or instead be used to direct fluids tothe desired target site, optionally with the assistance of a stopcock ordirect connection between the target lumen and a fluid source (notshown) outside the patient's body or located upon/within the apparatus214′ distal to the desired target site. For example, a dye, saline, oreven a plurality of small coils (behaving in a pseudo-fluidic manner)(none of these shown) could be directed to the desired target sitethrough the target lumen 2466.

As shown in FIG. 25, the apparatus 214′ according to the seventhembodiment may be provided to the patient's body similarly to other,earlier described embodiments of the present invention. As with thefirst embodiment, the target lumen 2466 provides a target pathway whichis attached to at least one target point 228′, at least a portion of thetarget pathway extends through the catheter lumen 218′, and the targetpathway is substantially spaced apart from the framing member body 226′(though the relatively small portion of the target lumen 2466 which isattached to the target point 228′ may be located adjacent or even incontact with the framing member body without destroying this“substantial spacing apart”). It is contemplated that multiple targetlumens 2466 (not shown) could be provided to the apparatus 214′,similarly to the multiple target wires shown at least in FIGS. 6-9 and14-18. It is also contemplated that a single target lumen 2466 may belarge enough to be associated with multiple target points 228′ at onetime. For example, a single target lumen 2466 could be sized to beattached to and/or substantially surround multiple or all of the targetpoints of the grid shown in FIG. 6.

FIGS. 26-27 illustrate an eighth embodiment of an apparatus 214″. Theapparatus 214″ of FIGS. 26-27 is similar to the apparatus of FIGS. 2-5and therefore, structures of FIGS. 26-27 that are the same as or similarto those described with reference to FIGS. 2-5 have the same referencenumbers with the addition of a double “prime” mark. Description ofcommon elements and operation similar to those in the previouslydescribed embodiments will not be repeated with respect to the eighthembodiment.

As shown in FIGS. 26-27, the target pathway includes a combination of atarget wire 230″ and a relatively short target lumen 2466″. At least aportion of the target lumen 2466″ serves also as a target point 228″.The target wire 230″ is either directly or indirectly attached to thetarget point 228″. For example, the target wire 230″ may pass through atleast a portion of the target lumen 2466″ and may be held in thatrelationship in any suitable manner.

Optionally, and as shown in FIGS. 26-27, a puncture needle 232″ may beassociated with at least one of the target lumen 2466″ and target wire230″ for insertion along with the framing member 220″ through thecatheter lumen 218″. In this manner, the puncture needle 232″ can beassociated with the structures of the apparatus 214″ before theapparatus is placed in the patient's body. When the puncture needle 232″is pre-associated in this manner, the framing member 220″, with attachedpuncture needle, is expanded as described above. The puncture needle232″ is then placed at the desired target site by the expansion of theframing member 220″ and may be remotely moved (e.g., via manipulation ofthe target wire 230″) to puncture the patient tissue at the desiredtarget site. When the target wire 230″ is used to move the punctureneedle 232″, it may be desirable for the target wire to be movablyattached to the target point 228″, such as for reciprocating orunidirectional axial movement with respect to the target lumen 2466″.

Though cardiovascular applications and environments of the apparatus 214are given as examples above, it is contemplated that the presentinvention may be used in any medical application (for example, insertionthrough the mouth/esophagus and puncturing from the stomach to theperitoneal cavity), or even nonmedical applications (for example,insertion through an electrical conduit and puncturing from the conduitinto an adjacent space between wall studs), as appropriate; anyprocedure requiring relatively precise location of a target site couldbe a suitable environment for use of the present invention. For example,body cavities with which the apparatus 214 can be used include, but arenot limited to, at least one of a left atrium, a right atrium, aperitoneal cavity, a chest cavity, a left atrial appendage, a rightatrial appendage, a left pulmonary vein, a blood vessel, a common iliacartery, a subintimal space, a portion of the heart, a gastrointestinalorgan, a genitourinary organ, a space external to the patient's body,and the like. Similarly, the body tissue may be, but is not limited to,at least one of an interatrial septum, a left atrial appendage wall, aright atrial appendage wall, a left pulmonary vein wall, a chest wall,an abdominal wall, a heart wall, a blood vessel wall, a common iliacartery wall, a gastrointestinal organ wall, a genitourinary organ wall,a skin of the patient, and the like. Indeed, a puncture need not alwaysbe the end result of using the present invention—the apparatus 214 couldbe applied instead, as discussed throughout, to simply precisely locate(and optionally mark) a specific area within a difficult-to-accessstructure.

It is also contemplated that, though the apparatus 214 is described asextending, in some example use environments, from an internal bodylocation all the way outside the patient's body, a second catheter,guidewire, trocar, stent, or the like (not shown) could be used to enterthe patient's body from externally in any manner, and at least a portionof the apparatus 214 could be linked with that second catheter,guidewire, trocar, stent, or the like inside the patient's body. In thismanner, the apparatus 214 can assist in placing the internal bodylocation in communication with an external structure, while theapparatus 214, or portions thereof, does not actually exit the patient'sbody.

While aspects of the present invention have been particularly shown anddescribed with reference to the preferred embodiment above, it will beunderstood by those of ordinary skill in the art that various additionalembodiments may be contemplated without departing from the spirit andscope of the present invention. For example, the framing member 220, orthe framing strands 652 thereof, may have any suitable shape,cross-sectional or otherwise (e.g., the framing member could have agenerally tubular aspect provided by loops of framing strands or couldresemble a conventional stent). The framing member 220, or the framingstrands 652 thereof, may self-expand through the use of memory alloymaterials, magnetic attraction/repulsion, or any other desiredmechanism. The functions of the framing strands 652 and target wires 230may be combined in a single structure. A wireless system may selectivelyprovide an electrical signal to the target points 228 similarly to thetarget wire 230 system. Any number of target points 228 in a target grid656 may have associated target wires 230. One or more framing members220 may have a protrusion 224 adapted to enter the superior vena cava106 or another defined body structure and thereby help position theapparatus 214 in a desired orientation. The framing cross members 654 emay be self-expanding and be restrained by the framing strands 652 e.The plurality of target points 228 need not be matched in shape, size,attachment method, conductivity, or any other property. The catheter 216may follow the framing member 220 through the body tissue, or thecatheter 216 may remain within the first body cavity. The framing member220 may extend through a series of body cavities after facilitatingpunctures through multiple body tissues. Only one apparatus 214 is shownas being present in the embodiments described and shown herein, but anynumber of apparatus 214 may be used at a time, as desired for aparticular application of the present invention. The apparatus 213 couldassist in puncturing outward from a first body cavity to a second bodycavity, and then successively inward to the first body cavity again. Adevice or method incorporating any of these features should beunderstood to fall under the scope of the present invention asdetermined based upon the claims below and any equivalents thereof.

Other aspects, objects, and advantages of the present invention can beobtained from a study of the drawings, the disclosure, and the appendedclaims.

1-29. (canceled)
 30. An apparatus for targeting a desired target site ona body tissue that separates a first body cavity from a second bodycavity of a patient, the apparatus comprising: a catheter having alongitudinally extending catheter lumen and adapted to provide access tothe first body cavity; a framing member having a collapsed condition inwhich the framing member is adapted for insertion into the first bodycavity through the catheter lumen and an expanded condition in which theframing member is adapted for placement within the first body cavity;and at least one target point carried by the framing member and adaptedfor placement adjacent the desired target site.